1. Field of the Invention
The invention relates to a disposable applicator, and more particularly to an applicator that can be used to apply a therapeutic or otherwise biomedically useful liquid composition to a surface, such as a biological tissue.
2. Description of Related Art
Numerous swabs and applicators for delivering biomedically useful compositions are known. Included among these are the flexible fluid dispensers disclosed in U.S. Pat. Nos. 5,035,348 and 5,100,028 to Seifert. Seifert discloses flexible fluid dispensers that include a top and bottom wall and a seal that seals the top wall to the bottom wall and is shaped to concentrate forces resulting from pressure generated by applying a force to the dispenser. The opening resulting from a break in the seal is proportional in size to the force applied to the dispenser. The applicator comprises a dispenser and a saturable end-piece. Force provided on the dispenser between two seals causes opening of one of the seals at a pre-determined site. Fluid contained within the applicator flows into the saturable end-piece, which can be used to apply the fluid.
U.S. Pat. No. 3,757,782 to Aiken discloses a fluid pressurizable swab applicator for medicament. The applicator is a double swab-ended applicator comprising an encapsulated charge of solution sealed between the extreme ends of a flexible plastic tubular applicator rod. One or both ends of the swab applicator can be saturated during use with the encapsulated charge (a medicament, antiseptic, or like solution). Manual pinching of the tubular applicator rod ruptures temporary seal elements at both of the tube ends. No manipulation or fracturing of an ampoule-like part, or specific removal of another type of sealing element is entailed.
U.S. Pat. Nos. 4,863,422 and 4,776,836, both to Stanley, disclose a double ended swab applicator for applying a treating liquid. The applicator supplies heated treating liquids such as medicaments, antiseptics and lubricants for direct application to a particular region of a patient""s body. As shown in detail in FIGS. 1-3, a liquid, such as a medicament, is contained in an inner lumen contained within a compressible and flexible synthetic plastic handle. Between the handle and the inner lumen is an outer lumen filled with a heat-generating material. Upon compression of the handle, the heat-generating material heats the liquid in the inner lumen. A frangible seal can then be ruptured by bending the applicator at the area around the frangible seal, allowing the liquid to flow into a compartment. The pressure produced by compression of the handle also ruptures a membrane and allows the liquid to flow into a swab. One membrane is non-rupturable, allowing a second swab to remain dry.
U.S. Pat. No. 4,430,013 to Kaufman discloses disposable swab articles comprising an applicator package having proximal ends and having a foam applicator pad and a backing member adjacent thereto. In use, the ends of the applicator package are pinched together, causing a receptacle to break open at a pre-weakened area, thus allowing the liquid within the receptacle to flow into a foam element. In an embodiment depicted in FIGS. 10 and 11, the applicator package has a sponge or foam swab applicator tip disposed at one end. The applicator further comprises a receptacle located within the handle that holds a liquid to be dispensed. The receptacle has a scored line located near the applicator tip that is a point of weakness for breaking the receptacle. Upon breaking of the receptacle at the scored line, the liquid within the receptacle flows out into the applicator tip. The disclosed applicator does not comprise a second sponge or foam swab at the end opposite the applicator tip end.
U.S. Pat. No. 5,690,958 to McGrath discloses a bactericidal agent dosage applicator comprising chlorhexadine gluconate contained within a manually-crushable glass ampoule. In one embodiment, shown in FIG. 2, an elongated cylindrical glass vial or ampoule is housed within an elongated, cylindrical, flexible, synthetic resin cover of a size to fully encase the vial. A porous applicator swab is fitted within one end of the applicator cover. To operate the applicator, the user crushes the vial by applying adequate force to the protective cover to break the side wall of the glass vial. The antiseptic solution released from the broken vial is quickly absorbed by the porous tip, thus permitting the user to apply the solution directly to the patient""s skin. McGrath does not disclose a second porous tip on the other end of the applicator.
U.S. Pat. No. 3,324,855 to Heimlich discloses a surgical sponge stick for removal of excess fluids during surgical procedures. The sponge stick comprises a hollow handle with a first open end and a second perforated end. The perforated end is surrounded by a porous absorbent surgical sponge material. The sponge stick may be used in preparing a patient for surgery by incorporating an antiseptic solution within the stick. FIG. 4 discloses an embodiment wherein the liquid or solution to be applied is contained in a frangible cartridge disposed in the handle and retained therein by a stop secured inside the handle adjacent an open end. The frangible cartridge or ampoule is broken by squeezing or flexing the handle, allowing the liquid to flow into the sponge.
U.S. Pat. No. 5,445,462 to Johnson et al. discloses a liquid applicator with both upper and lower open ends and a porous material attached to a tip as part of one end. A closed, frangible ampoule is supported within the end that does not comprise the tip and contains a liquid to be dispensed. A cap is located at the end opposite the tip that is movable to fracture the ampoule and release its contents. The body of the applicator is preferably formed of a resilient material such as thin-walled plastic material or the like, and fluid is pressured through the tip onto the application point.
U.S. Pat. No. 5,658,084 to Wirt discloses an article useful as a dispenser for the application of a liquid. The article is an applicator that comprises a rupturable reservoir containing a solution, a hollow elongate member that has a major orifice at one end and contains the rupturable reservoir, deformable means contained within the hollow elongate member for supporting and protecting the reservoir until the liquid is to be dispensed, means for limiting the axial displacement of the deformable means, and means for rupturing the reservoir. The deformable means has an aperture through which at least a portion of the reservoir may be pushed. The means for rupturing the reservoir functions after at least a portion of the reservoir is pushed through the aperture in the deformable means. Upon rupture of the reservoir, the solution is applied through a foam sponge. The rupturable reservoir, or frangible ampoule, comprises a stress-concentrator between the ampoule neck portion and body portion to serve as a break point for the ampoule.
U.S. Pat. No. 5,308,180 to Pournoor et al. discloses an article for the application of a liquid to a surface. The article is a dispenser for application of a liquid to a surface that comprises a hollow elongate member that has a major orifice at one end, a flexible, porous layer disposed over the major orifice, a layer of sponge material disposed over the exterior surface of the porous layer, and a means of maintaining atmospheric pressure within the hollow elongate member while the liquid to be applied by the applicator is being dispensed. The flexible, porous layer of porous material is disposed over the first major orifice of the hollow elongate member, and is sandwiched between a flange and the foam sponge. The porous layer is disposed over the major orifice to control the flow of liquid out of the hollow elongate member and into the foam sponge.
It is also known to use adhesives in wound closure and covering. For example, U.S. Pat. No. 3,559,652 to Coover et al. discloses the use of cyanoacrylate adhesives to close wounds or incisions by applying the adhesive composition to one or both surfaces of the wound or incision, then holding the two surfaces together until the two surfaces are bonded. U.S. Pat. No. 3,667,472 to Halpern discloses a different method for wound closure wherein a cyanoacrylate adhesive is applied across two abutted tissue surfaces to form a bridge between the two surfaces. The tissue surfaces are held together until the adhesive forms a bond between the two surfaces. Other adhesive compositions and methods of wound closure are disclosed in, for example, U.S. Pat. Nos. 5,328,687 to Leung et al.; 3,527,841 to Wicker et al.; 3,722,599 to Robertson et al.; 3,995,641 to Kronenthal et al.; and 3,940,362 to Overhults.
A method for application of a topical cyanoacrylate tissue adhesive is disclosed in product literature accompanying Histoacryl(copyright) cyanoacrylate adhesive, which is commercially available from B. Braun Melsungen AG of Germany.
U.S. Pat. No. 5,928,611 (International Application No. PCT/US96/09575 to Closure Medical Corporation, published as International Publication No. WO 96/40797), discloses an applicator and tip for dispensing a polymerizable and/or cross-linkable material. The applicator includes a container holding a polymerizable and/or cross-linkable material, an optional plunger for forcing the material from the container, and an applicator tip having a portion thereof with a polymerization and/or cross-linking initiator. The tip is porous and absorbent or adsorbent. The polymerization or cross-linking initiator can be coated on an interior surface of the applicator in the case where the material is contained in a frangible vial within the applicator.
Commonly assigned U.S. patent application Ser. No. 09/343,914, filed Jun. 30, 1999, discloses monomeric adhesive composition comprising a polymerizable 1,1-disubstituted ethylene monomer and a flavoring additive, and methods of making and using such a composition. In these compositions, the flavoring additive is mixed directly with the monomeric adhesive.
Although it is known to make and use applicators for dispensing medicinal or therapeutic liquids, none of the applicators currently known provide a disposable applicator that is optimized for convenient application of a biomedically useful adhesive composition to biological tissue. The known applicators are either optimized for delivery of other compositions or are inconvenient for the patient to use.
Because there is a need for an easy-to-use applicator for dispensing and applying biomedically useful compositions, the present invention provides a disposable applicator that can be used by a person, such as a patient, to apply such a composition conveniently, inexpensively, and effectively.
The applicator of the present invention is generally tubular in shape, having a single open distal end and a closed, sealed proximal end. Both ends are covered by an absorbent material, such as a sponge or foam. The applicator holds a biomedically useful liquid composition that can be dispensed and applied to a surface. The composition is maintained, until applied, in a frangible vial within the applicator. The liquid composition is dispensed through the open distal end only, and applied to the target site by wiping or rubbing the absorbent material covering the distal end on the site. The closed end is covered with an absorbent material that can be used prior to application of the liquid composition to dry the surface on which the liquid composition is to be applied.
The applicator is designed for simple and effective delivery of liquid compositions to target sites. The applicator is designed for single-handed use by a person with average strength, and requires little or no instruction prior to its use. The design is simple in construction (as compared to many applicators known in the art) and use, having no moving parts and requiring no special disposal procedures. Application of a biomedically useful composition contained within the applicator thus does not need to be supervised by a medical professional, but can be performed by the user in the environment, and at the time, chosen by the user.